Pozelimab-bbfg Injection

pronounced as (poe zel′ i mab)

Brand Name(s): Veopoz®

Why is this medicine prescribed?

Pozelimab-bbfg injection is used in adults and children 1 year of age and older to treat CD55-deficient protein-losing enteropathy (PLE; CHAPLE disease; an inherited condition in which the immune system mistakenly attacks and destroys healthy cells in the digestive tract). Pozelimab-bbfg is in a class of medications called complement inhibitors. It works by blocking the activity of the part of the immune system that may damage cells in the digestive tract.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Pozelimab-bbfg injection comes as a solution (liquid) to be injected intravenously (into a vein) and subcutaneously (under the skin) by a healthcare provider. The first dose of pozelimab-bbfg injection is usually infused (injected slowly) intravenously over a period of at least 1 hour. Thereafter, it is usually given subcutaneously once a week, starting 8 days after the first intravenous dose.

Pozelimab-bbfg injection may cause serious allergic reactions. Your doctor will watch you carefully for 30 minutes after you receive your intravenous infusion and after your first subcutaneous injection of the medication. Your doctor may slow or stop your intravenous infusion if you have an allergic reaction. If you experience any of the following symptoms, tell your doctor immediately: hives; chest pain; difficulty breathing; shortness of breath; swelling of your face, tongue, or throat; or feeling faint.

What special precautions should I follow?

Before receiving pozelimab-bbfg injection,

  • tell your doctor and pharmacist if you are allergic to pozelimab-bbfg, any other medications, or any of the ingredients in pozelimab-bbfg injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had any other medical condition(s).
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving pozelimab-bbfg injection, call your doctor.
  • check with your doctor to see if you need to receive any vaccinations before receiving pozelimab-bbfg injection. Do not have any vaccinations without talking to your doctor.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

If you miss an appointment to receive a dose of pozelimab-bbfg injection, call your doctor right away.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What side effects can this medicine cause?

Pozelimab-bbfg injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • hair loss
  • redness, swelling, and itching at the injection site
  • bleeding gums

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

  • bone fracture

Pozelimab-bbfg injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( http://www.fda.gov/Safety/MedWatch ) or by phone (1-800-332-1088).

What other information should I know?

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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